levetiracetam

Generic: levetiracetam

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-122
Product ID 82009-122_4090ba40-7f20-ea57-e063-6294a90acaa8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090515
Listing Expiration 2026-12-31
Marketing Start 2023-07-19

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009122
Hyphenated Format 82009-122

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0382009121055 0382009123059 0382009124605 0382009122052
UNII
44YRR34555
NUI
N0000008486

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name levetiracetam (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA090515 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (82009-122-05)
source: ndc

Packages (1)

82009-122-05 500 TABLET, FILM COATED in 1 BOTTLE (82009-122-05)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4090ba40-7f20-ea57-e063-6294a90acaa8", "openfda": {"nui": ["N0000008486"], "upc": ["0382009121055", "0382009123059", "0382009124605", "0382009122052"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["3756f052-919c-4817-a56e-1091fd514d9d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-122-05)", "package_ndc": "82009-122-05", "marketing_start_date": "20230719"}], "brand_name": "Levetiracetam", "product_id": "82009-122_4090ba40-7f20-ea57-e063-6294a90acaa8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "82009-122", "generic_name": "Levetiracetam", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA090515", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}